Show your working: evidence as the key to successful medtech innovation

3rd April, 2020

By Chris Warwick, MedTech Consultant at Health Enterprise East

Originally published by Med-Tech Innovation News

The adoption and spread of medtech innovations has long been a challenge in the NHS, particularly for SMEs. The Long Term Plan acknowledges that this process needs to be faster, clearer and simpler, so that innovations, and their benefits, get to patients and clinicians faster.

The barriers faced by innovators can be frustrating, not to mention costly, particularly when feedback on their ideas at the outset seemed positive. What lies behind this change from enthusiastic reception during the early development phase to lukewarm interest later on?

“Everybody loves it”

When quizzing innovators about the attributes of their fledgling innovations, we are invariably told “everybody seems to love it”. Yet this cannot drive a new product to market, not least because the response to a theoretical concept will not necessarily align with that of a real-life product. While identifying potential and promoting end-user appeal from the outset is important, the project must be underpinned by an evidence-based approach that highlights the specific clinical need, and maintains this focus throughout the development process.

Despite the understandable urge to press ahead, skimming over the evidence-gathering phase can be a costly mistake, and could mean that claims of an innovation’s market appeal are realised too late in the day.

Who needs evidence?

A range of evidence is required for various stakeholders involved in the development and adoption of medtech innovations, and each of these groups will have concerns which evidence can help to allay. This includes patients, clinical teams, hospital decision makers and investors.

Independent bodies, such as Health Enterprise East, can help to identify the evidence required and provide guidance on how to evaluate it. This advice can assist with evidence gathering, help to obtain guidance on trials and begin the process of securing commercial appetite for the innovation. Such support can also provide opportunities for innovators to connect with clinicians to get a wider viewpoint, as well as identify product development companies and potential investors.

Evidence for every stage

Evidence is required at every step of the development process; right from idea generation through to adoption and scaling. Importantly, early buy-in from stakeholders at the initial evaluation stage must be secured, as this helps to prepare timelines for ethical approval, patient recruitment and any staff training requirements, plus ensuring that key infrastructure is in place.

The first stage in the evaluation of trials is to explore the perceived benefits and classify them into clinical, operational, economic and patient benefits. The purpose of this is to identify the benefits for all key stakeholders, so reinforcing the innovation’s value proposition.

This not only helps to promote engagement with everyone involved, but those at the forefront of clinical care may see advantages of the innovation that are not immediately obvious to others. For example, clinicians may identify that one of the key advantages of a new device is that it is smaller and more portable, freeing up clinical time and making it easier to be used across multiple wards.

Next, potential metrics which can be recorded, collected or observed must be identified to evidence the change the innovation brings, then categorised into qualitative and quantitative benefits. In order to demonstrate the direct impact of the innovation, the benefits that can be directly attributed to the introduction of the innovation, rather than alternative improvements, should be identified. For example, innovations developed primarily to reduce waiting times (e.g. in mental health) could be skewed by other initiatives being introduced by a Trust, given this is an NHS priority.

A further round of classification involves identifying which benefits would potentially be cash-releasing; those which offer financial benefits, but not cash-releasing savings (such as saving clinical time); and those which would bring non-financial benefits (such as reduced staff stress).

The necessary baseline

The next step is for timelines to be decided for the collection of both baseline and post-implementation data.

Depending on the metrics selected, baseline data may need to be collected prior to roll-out. For example, if the innovation is aimed at saving clinicians’ time, then this evidence might be measured by carrying out a time and motion study to record how clinicians use the current device, then repeated and compared following implementation of the innovation. This allows direct measurement of interaction, as well as the collection of qualitative data regarding ease of use.

As time and motion studies can be resource intensive, baseline data can also be collected retrospectively. For example, if the innovation aims to reduce the number of GP appointments, then historical, longitudinal data can be collected from clinical IT systems.

Once the data is in and the analysis is complete, the key challenge becomes working out precisely what the evidence shows: are there patient benefits? Can changes be attributed to the introduction of the innovation? Do clinicians find it both useful and easy to use? Is there evidence of cash-releasing benefits, or is it more qualitative? This helps to define whether the product is ready for adoption and if there is a business case for further spread.

What about investors?

Although often the forgotten party, it is also important to consider the evidence that investors might need.

Investors will often seek evidence that an innovation will give them a good return on investment (ROI). This might involve performing a review of the innovation’s intellectual property position; a scan of competitors; the potential and projected market share; validation of need and benefits; as well as evidence of the health economic advantages that the innovation offers. This analysis assesses whether the innovation provides value relative to an existing intervention and evaluates whether it is affordable to the end-user. This evidence can be used to assess both the ROI for the target customer (e.g. the NHS), as well as the potential investor.

The end result

A thorough, evidence-based analysis is the most effective way to gain a deeper understanding of the broader potential benefits of an innovation. By gauging benefits in the round, a complete picture of the potential impact of an innovation can be compiled. This in turn will increase chances of securing investment and will boost the odds of wider adoption.

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